As reported in the Journal of Clinical Oncology by Willems et al, venous thromboembolism (VTE) occurred in a high proportion of patients with resectable/borderline resectable pancreatic ductal adenocarcinoma receiving neoadjuvant FOLFOXIRI (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin) or neoadjuvant gemcitabine-based chemoradiotherapy (CRT) followed by adjuvant gemcitabine.
Study Details
The study involved data from the phase III PREOPANC-2 trial, in which 325 patients were randomly assigned to receive neoadjuvant FOLFIRINOX (n = 158) or neoadjuvant gemcitabine-based chemoradiotherapy and adjuvant gemcitabine (CRT group, n = 167). VTE was defined as incidental or symptomatic lower- or upper-extremity deep vein thrombosis, pulmonary embolism (PE), splanchnic vein thrombosis, or catheter-related thrombosis. VTE occurrence was assessed for 12 months after random assignment.
Key Findings
In the year after random assignment, 28 patients (9%) developed VTE, including 9 in the FOLFIRINOX group and 19 in the CRT group; VTE occurred preoperatively in 9 patients and postoperatively in 19 patients. VTE was symptomatic in 15 patients. The 3-month cumulative incidence was 2% in the total population, including 3% in the FOLFIRINOX group vs 2% in the CRT group (P = .059).
Preoperative VTE occurred in 5 patients in the FOLFIRINOX group vs 4 in the CRT group (P = .75). Postoperative VTE occurred in 4 vs 15 patients (P = .02). The overall 12-month cumulative incidence was 6% vs 11% (P = .06).
Death due to PE-related causes occurred in two patients in the CRT group. VTE was independently associated with reduced overall survival (adjusted time-varying hazard ratio = 2.13, P = .002).
The investigators concluded: “VTE occurred in 9% of patients with (borderline) resectable [pancreatic ductal adenocarcinoma] undergoing (neo)adjuvant treatment in the year after random assignment and was associated with decreased [overall survival]. These results underscore the need for standardized reporting of thromboembolic events in clinical trials and future studies assessing the potential benefits of thromboprophylaxis during neoadjuvant therapy.”
Judith de Vos–Geelen, MD, PhD, of the Division of Medical Oncology, Maastricht University Medical Center, Maastricht, the Netherlands, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by the Dutch Cancer Society and ZonMw. For full disclosures of the study authors, visit ascopubs.org.
